Oxygen Insufflation Via Flexible Scope

Официальное название

Oxygen Insufflation Via a Flexible Scope to Remove Secretions and Blood Obstructiong the View When Advancing the Scope Towrds the Trachea

Обзор

The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained

Подробное описание

The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained

Вмешательства

• Процедура addition of oxygeninsufflation via working channel of flexible scope
  addition of oxygeninsufflation via working channel of flexible scope in order to improve visibility when advancing the flexible scope
• Процедура no-oxygen insufflation
  no-oxygen insufflation added to the flexible scope while advancing it

Первичные конечные точки

• The fraction of bronchoscopic advancements that result in a view of vocal cords (Fully or partial) without the view being obstructed by saliva or blood during the advancement [Срок оценки: 90 seconds]

Вторичные конечные точки (11)

• The scope is advanced to the trachea within 2 minutes [Срок оценки: 2 minutes]
• Duration until the tip of the scope is in the trachea [Срок оценки: 0-2 minutes]
• Operation percieved ease of advancing the scope to the trachea with maintained visibility [Срок оценки: 2 minutes]
• Operation percieved ease of advancing the scope to the trachea, overall [Срок оценки: 2 minute]
• The scope is advanced to the trachea within 1 minute [Срок оценки: 1 minute]
• unobstructed advancement to the trachea in two minutes [Срок оценки: 2 minute]
• unobstructed advancement to the trachea in 90 seconds [Срок оценки: 90 seconds]
• Obtaining a view of vocal cord(s) without obstruction of the view, obtained in 30 seconds [Срок оценки: 30 sekunds]
• Obtaining a view of vocal cord(s) without obstruction of the view, obtained in one minute [Срок оценки: 1 minute]
• Obtaining a view of the vocal cord(s) without obstruction of the view, obtained in 90 seconds [Срок оценки: 90 seconds]
• The fraction of brochoscopic advancements that results in Unobstructed advancement to the trachea in one minute [Срок оценки: 1 minute]

Критерии участия

Критерии включения

Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"

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Критерии исключения

• non acceptance of participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Rigshospitalet, Unoversity Hospital of Copenhagen — Copenhagen

Публикации

• Garioud A, Kristensen MS. Oxygen insufflation via the working channel during tracheal intubation guided by a flexible optical scope and benefits, dangers, and future of the method: a narrative review. BJA Open. 2024 Oct 17;12:100346. doi: 10.1016/j.bjao.2024.100346. eCollection 2024 Dec. PMID 39469423

Идентификаторы

NCT: NCT06680648 · OxygenInsufflation_F-24066560

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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